Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia:A Group Randomized Controlled, Add on Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Duration of invasive mechanical ventilation
研究概览
简要总结
Article: Clinical Outcomes of Inhaled Amikacin in Ventilator-Associated Pneumonia: A group randomized controlled,add-on trial English:Patients in intensive care units often need ventilators to breathe. Sadly, these machines sometimes cause serious lung infections, known as ventilator-associated pneumonia (VAP). This study tested whether giving the antibiotic amikacin by inhalation (so itgoes straight into the lungs) could improve recovery when added to regular treatment. Researchers looked at how quickly infections cleared, how long patients needed the ventilator, and whether hospital stays were shortened. They also monitored for side effects.
详细描述
Ventilator-associated pneumonia continues to pose a significant therapeutic challenge due to rising antimicrobial resistance and suboptimal lung penetration of systemic antibiotics. Inhaled amikacin offers the advantage of delivering high local drug concentrations in the respiratory tract with minimal systemic toxicity.
This group randomized controlled add-on trial was conducted in the Surgical Intensive Care Units of Lahore General Hospital, Pakistan, from January to December 2024. A total of 180 adult patients diagnosed with VAP were allocated to one of two treatment arms:
Group N (Control): Empirical intravenous antibiotics (Meropenem ± Moxifloxacin)
Group A (Intervention): Inhaled amikacin (20 mg/kg/day in two divided doses) in addition to empirical intravenous antibiotics
Randomization was computer-generated and stratified by age, gender, and baseline SOFA score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was applied. Due to nature of treatmeht, both the treating clinicians and participants, representatives were aware of the assigned treatment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Participants must meet all of the following:
- •Age 18-80 years
- •Currently receiving invasive mechanical ventilation
- •Clinical diagnosis of ventilator-associated pneumonia (VAP) based on:
- •New or progressive infiltrate on chest imaging and at least two of the following:
- •Fever > 38°C or hypothermia < 36°C
- •Leukocytosis >12,000 or leukopenia <4,000 cells/µL
- •Increased purulent respiratory secretions
- •Worsening oxygenation indices
- •Initiation of systemic IV antibiotics for VAP
- •Availability of baseline respiratory sample for culture
- •Informed consent obtained from patient's legal guardian/attendant
排除标准
- •Any of the following will lead to exclusion:
- •Known hypersensitivity to aminoglycosides (e.g., amikacin)
- •Chronic kidney disease Stage 4-5 or baseline serum creatinine >2 mg/dL
- •Pre-existing hearing loss or vestibular dysfunction
- •Severe bronchospasm or airway instability preventing safe nebulization
- •VAP due to confirmed pan-resistant microorganisms requiring alternative therapy
- •Exclusion Criteria:
研究组 & 干预措施
Inhaled Amikacin + Standard-of-Care Antibiotics
Participants will receive inhaled amikacin administered via nebulization in addition to standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol.
干预措施: Amikacin (Inhalation) (Drug)
Inhaled Amikacin + Standard-of-Care Antibiotics
Participants will receive inhaled amikacin administered via nebulization in addition to standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol.
干预措施: Standard-of-Care Intravenous Antibiotics (Drug)
Participants will receive ONLY standard of care antibiotics
Participants will receive only standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol.
干预措施: Standard-of-Care Intravenous Antibiotics (Drug)
结局指标
主要结局
Duration of invasive mechanical ventilation
时间窗: From randomization until successful discontinuation of mechanical ventilation, assessed up to 28 days
The total number of consecutive days a participant remains on invasive mechanical ventilation following enrollment. Extubation is considered successful if the participant remains off the ventilator for at least 48 hours without the need for reintubation.
次要结局
- Clinical Improvement on Day 7(Day 7 after initiation of study treatment)
研究者
Anum Anwar
Assistant Professor Anaesthesia/ICU
Postgraduate Medical Institute, Lahore